2026 Medicare PFS Proposed Rule Addresses Cell and Gene Therapy Payments, Therapeutic Apheresis

The Centers for Medicare and Medicaid Services (CMS) released the calendar year (CY) 2026 Medicare Physician Fee Schedule (PFS) proposed rule, which was published today in the Federal Register. The agency also released an accompanying fact sheet.

Cell and Gene Therapy Payments

In the proposed rule, CMS outlined plans to modify how Medicare reimburses preparatory procedures (manufacturing steps) associated with autologous cell-based immunotherapies and gene therapies.

Specifically, the agency proposes to include preparatory procedures for tissue procurement required for manufacturing these therapies in the payment for the product itself, rather than reimbursing separately for each step of the collection and manufacturing process.

AABB, along with other organizations in the biotherapies community, previously urged CMS to treat CAR-T services as distinct clinical services in the hospital outpatient setting and assign appropriate status indicators and Ambulatory Payment Classifications to ensure separate reimbursement. AABB will continue to advocate for separate payments for these important processes.

Additionally, CMS proposes that, beginning Jan. 1, 2026, any manufacturer-paid preparatory procedures for tissue procurement be included in the calculation of the manufacturer’s average sales price (ASP). While the agency noted limited information on how manufacturers currently factor these costs into pricing, CMS stated that tissue procurement typically represents a small fraction of overall product costs and expects any impact on Medicare payment to be minimal.

Therapeutic Apheresis

CMS also responded to a nomination to review CPT code 36514 (therapeutic apheresis) as potentially misvalued due to concerns with the clinical labor and equipment inputs used in the code’s valuation. The nominator asserted that the current clinical labor code, L056A (RN/OCN), undervalues the operating cost of a therapeutic apheresis nurse and questioned the pricing and utilization rate of equipment code EQ084 (cell separator system).

In response, CMS stated it does not currently have sufficient information to determine whether the code is potentially misvalued. However, the agency is seeking public comment and supporting data to further evaluate the relevant practice expense inputs. Specifically, CMS requested input on whether to establish a new clinical labor code for therapeutic apheresis nurses in the non-facility setting and invited submission of invoices and related documentation to inform a potential update to the pricing of the cell separator system. CMS disagreed with the nominator’s suggestion to lower the equipment utilization rate to 21%, reaffirming its standard 50% utilization assumption for most equipment.

Submitting Comments on the Proposed Rule

CMS is accepting feedback on the proposed rule until Sept. 12. Instructions are available in the Federal Register notice.